DETAILED ACTION
This action is pursuant to claims filed on 01/27/2026. Claims 1-3, 8-10, 12-15, and 18-19 are pending. An action on the merits of claims 1-3, 8-10, 12-15, and 18-19 is as follows.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 13, the claim recites the limitation “at least one of a reference electrode, a working electrode, and a counter electrode is disposed on the first surface and the second surface” in lines 4-5. It is unclear how the at least one electrode can be on both the first surface and the second surface, as this limitation only requires one electrode. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as only requiring an electrode to be on either the first surface or the second surface, not both.
Regarding claim 14, the claim recites the limitation “at least one of a reference electrode, a working electrode, and a counter electrode is disposed on the first surface and the second surface” in lines 5-6. It is unclear how the at least one electrode can be on both the first surface and the second surface, as this limitation only requires one electrode. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as only requiring an electrode to be on either the first surface or the second surface, not both.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 8-10, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20190159337) in further view of Garai (US 20200330007).
Regarding independent claim 1, Wang teaches a sensing device ([0139]: “FIG. 15 shows a diagram of an example stretchable wearable sensor 1500 in accordance with the present technology. The example stretchable sensor 1500 is shown in FIG. 15 as configured as a 3-electrode electrochemical sensor, and it is understood the example stretchable sensor 1500 can include fewer or greater electrodes, and can be configured for other sensor applications, such as electrophysiological sensing or other.”) comprising:
a sensor which includes a flexible substrate ([0054]: “The present technology includes a highly stretchable rechargeable battery that can be printed onto stretchable substrates and later applied to no curvilinear substrates such as skin, textiles, and robotics”. The stretchable battery layer 1601 is the flexible substrate.), an electrode disposed on the flexible substrate ([0006]: “a stretchable electronics device includes a stretchable substrate including an elastic and electrically insulative material structured to conform to an outer surface of an object; and an electrode arranged over the stretchable substrate”; [0065]: “This ratio was utilized to fabricate the example carbon current collector electrode for the stretchable Zn—Ag.sub.2O battery”. The electrode is attached to the stretchable battery layer 1601 and the stretchable substrate, and therefore is disposed on the flexible substrate.), and a connection terminal disposed on the flexible substrate and connected to the electrode ([0140]: “The device base 1605 can include supportive electronics units, such as communication and power management, sensor electronics”; [0140]: “FIG. 16 shows a diagram of an example stretchable battery 1600 configured as a stretchable battery layer 1601 attached to an adhesive 1603, which attaches to skin of a user or other surface of an object, and electrically coupled to a support base 1605 of a sensor device, e.g., such as an electronics unit and/or sensor unit”. The electronics units are the connection terminal, which are disposed on the stretchable battery layer 1601.); and
a stretchable substrate ([0006]: “a stretchable electronics device includes a stretchable substrate” ; [0120]: “a stretchable substrate 1422”) which is connected to the sensor ([0139]: “The sensor 1500 includes a stretchable substrate 1501”; [0121]: “The example design of the island-bridge structure shown in FIGS. 14A-14D is quite adaptable to various technologies, e.g., especially for electrochemical devices such as batteries, biofuel cells, supercapacitors, and chemical sensors”; [0214]: “Certain features that are described in this patent document in the context of separate embodiments can also be implemented in combination in a single embodiment”. It would have been obvious to combine the island-bridge structures from figures 14A-14D into a single embodiment since Wang teaches that features of the embodiments may be combined into a single combination and it would provide a multi-functional device.) and includes a stretchable base ([0080]: “the example substrate 505 includes a thermoplastic PU sheet 505a that is thermally-bonded to a flexible base substrate”) and a line disposed on the stretchable base ([0107]: “FIG. 11A shows an illustrative diagram depicting an example screen-printing, fabrication method to produce a stretchable IB electronics device using elastic carbon ink as functional islands and followed by elastic, silver bridges in a serpentine configuration (e.g., line width greater than 150 microns)”; Figs. 11B-11J. The bridges are the lines disposed on the stretchable base.),
wherein the connection terminal of the sensor is connected to the line of the stretchable substrate ([0107]: “FIG. 11A shows an illustrative diagram depicting an example screen-printing, fabrication method to produce a stretchable IB electronics device using elastic carbon ink as functional islands and followed by elastic, silver bridges in a serpentine configuration (e.g., line width greater than 150 microns)”; Figs. 11B-11J. The bridges are the lines disposed on the stretchable base which are used to connect the components of the sensor, which includes the connection terminal.).
However, Wang does not teach wherein the line includes a plurality of line layers which are stacked, wherein each of the plurality of line layers includes a support layer embedded in the stretchable base and a metal layer disposed on the support layer, and wherein the connection terminal is disposed on the metal layer.
Garai discloses a sensor for measuring analytes including flexible substrates. Specifically, Garai teaches wherein the line includes a plurality of line layers which are stacked (Figs. 14-23),
wherein each of the plurality of line layers includes a support layer and a metal layer received in a groove formed in a base, wherein a side surface of the support layer and a side surface of the metal layer contact an inner wall of the groove, wherein the metal layer is disposed on an upper surface of the support layer ([0066]: “the substrate 20 is shown to include a top layer 91 and a bottom layer 92. In an exemplary embodiment, the top layer 91 and the bottom layer 92 are a flexible, electrically insulating material, such as polyimide, though other suitable materials may be used”; [0068]: “the substrate 20 includes an intermediate layer 93 between the top layer 91 and the bottom layer 92. In an exemplary embodiment, the intermediate layer 93 is a flexible, electrically insulating material, such as polyimide, though other suitable materials may be used. Flexible conductive layers 94, such as a metallization layers, are located between the intermediate layer 93 and each of the top and bottom layers 91 and 92. The substrate 20 further includes adhesive layers 95 between each respective layer 91, 92, and 93 and the respective conductive layers 94. Exemplary conductive layers 94 are copper, platinum or another suitable metal. As is well known, each conductive layer 94 may be patterned to form a desired circuitry. Further, such patterning may provide for etching or otherwise forming vias through the intermediate layer 93 and for filling the vias with the conductive material of the conductive layers 94”. The intermediate layer 93 is the support layer, and the conductive layer 94 is the metal layer.; Figs. 16 and 17 show the intermediate layer and metal layer in a groove of a base (110), with a side surfaces of the intermediate layer and the metal layer in contact with an inner wall of the groove. The figure also shows the metal layer on the upper surface of the support layer, using an adhesive layer to connect them.), and
wherein the connection terminal is disposed on an upper surface of the metal layer (Fig. 15; [0069]: “The integrated circuit device 40 is directly electrically connected to, and integrated with, the directly underlying conductive layer 94”. The integrated circuit device is analogous to the connection terminal, which is directly integrated with the underlying metal layer, which implies the connection terminal being disposed on the upper surface of the metal layer.). Wang and Garai are analogous arts as they are both related to sensor systems used for monitoring analyte levels.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plurality of line layers and structures from Garai into the sensing device from Wang as it allows for more connections, which can improve the function of the sensing device. Additionally, the structure of the connections from Garai can provide more support and structure to the lines from Wang, therefore improving the device with a known connection type.
Regarding claim 2, the Wang/Garai combination teaches the sensing device of claim 1, wherein the connection terminal of the sensor is disposed between two line layers among the plurality of line layers (Garai, Figs. 16-17, circuit device 40 being between the layers.).
Regarding claim 3, the Wang/Garai combination teaches the sensing device of claim 2, wherein the stretchable base is disposed between adjacent line layers among the plurality of line layers (Garai, Figs. 14-23).
Regarding claim 8, the Wang/Garai combination teaches the sensing device of claim 1, wherein: the flexible substrate is divided into an electrode region in which the electrode is disposed and a connection terminal region in which the connection terminal is disposed; and a width of the connection terminal region is greater than a width of the electrode region (Wang, Fig. 16, stretchable battery layer (1601) contains the connection terminals and the device base (1605) contains the electrodes and additionally showing that the device base (containing the electrode region) was a smaller width than the battery layer (containing the connection terminal region).).
Regarding claim 9, the Wang/Garai combination teaches the sensing device of claim 1, wherein: the line of the stretchable substrate includes a plurality of pads (Wang, Figs. 13A-13I: functional islands) and a connector configured to connect the plurality of pads (Wang, Figs. 13A-13I: Island-bridges); and a width of the connection terminal is different from a width of a pad of the plurality of pads (Wang, Figs. 13A-13I).
Regarding claim 10, the Wang/Garai combination teaches the sensing device of claim 9, further comprising an adhesive portion disposed between the connection terminal and the pad (Wang, [0140]: “FIG. 16 shows a diagram of an example stretchable battery 1600 configured as a stretchable battery layer 1601 attached to an adhesive 1603, which attaches to skin of a user or other surface of an object, and electrically coupled to a support base 1605 of a sensor device, e.g., such as an electronics unit and/or sensor unit. The stretchable battery 1601 can include any of the example embodiments of the stretchable battery in accordance with the present technology. In the example shown in FIG. 16, the stretchable battery layer 1601 can be integrated into the adhesive layer 1603 to form an adhesive patch, which can be applied to any surface, e.g., skin. The device base 1605 can include supportive electronics units, such as communication and power management, sensor electronics, etc., which can be a mounted dongle that attaches to the adhesive patch. The example stretchable device design would extremely reduce the bulk associated with conventional wearable sensors, and make the wearable device more compliant and therefore more comfortable to a user.”).
Regarding claim 18, the Wang/Garai combination teaches the sensing device of claim 2.
However, the wang/Garai combination is silent on the material of the metal layer and the support layer.
Garai teaches wherein the metal layer includes at least one of Au, Cu, Pt and Ag ([0068]: “Exemplary conductive layers 94 are copper, platinum or another suitable metal”) and the support layer includes at least one of LCP (liquid crystal polymer), PEEK (poly ether ether ketone) and PI (polyimide) [0068]: “the intermediate layer 93 is a flexible, electrically insulating material, such as polyimide, though other suitable materials may be used”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the materials of the layers from Garai into the Wang/Garai combination as the combination is silent on the materials used, and Garai discloses suitable materials in an analogous device.
Regarding claim 19, the Wang/Garai combination teaches the sensing device of claim 9, wherein the connector includes a repeated curved pattern (Wang, [0206]: “a first electrical interconnection structure and a second electrical interconnection structure each attached to the stretchable substrate and having a periodic curved horseshoe geometry configured to connect unit cell regions positioned on the electrical interconnection structure”; Figs. 13A-13I).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Garai combination as applied to claim 2 above, and further in view of Hoss (US 20240415419).
Regarding claim 12, the Wang/Garai combination teaches the sensing device according to claim 2.
However, the Wang/Garai combination does not teach wherein the flexible substrate includes a first surface and a second surface opposite to the first surface; the connection terminal of the sensor is disposed on the first surface; and a signal processing circuit pattern configured to process a signal received from the electrode through the connection terminal is further disposed on the first surface.
Hoss discloses analyte measurement systems. Specifically, Hoss teaches wherein:
the flexible substrate includes a first surface and a second surface opposite to the first surface; the connection terminal of the sensor is disposed on the first surface (Claim 17: “a sensor substrate including a first side having a first surface area and defining a first side of the glucose sensor, and a second side having a second surface area and defining a second side of the glucose sensor, a first conductive layer disposed on the first side, wherein the first conductive layer substantially covers the first surface area, a second conductive layer disposed on the second side, wherein the second conductive layer substantially covers the second surface area”); and
a signal processing circuit pattern configured to process a signal received from the electrode through the connection terminal is further disposed on the first surface ([0048]: “The data processing unit 102 performs data processing functions, where such functions may include, but are not limited to, filtering and encoding of data signals, each of which corresponds to a sampled analyte level of the user, for transmission to the primary receiver unit 104 via the communication link 103.”). Wang and Hoss are analogous arts as they are both related to sensor systems used for monitoring analyte levels.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the layers facing multiple surfaces and the sensing device having a signal processing unit from Hoss into the device from Wang, since it allows the device to have more connections in different directions, which allows the device to accommodate more components and create more direct paths between the components of the device, as well as allow the device to process the signals it receives to provide further results to the user.
Regarding claim 13, the Wang/Garai combination teaches the sensing device of claim 2.
However, the Wang/Garai combination does not teach wherein: the flexible substrate includes a first surface and a second surface opposite to the first surface; at least one of a reference electrode, a working electrode, and a counter electrode is disposed on the first surface and the second surface; and a plurality of connection terminals identical to the connection terminal are disposed on at least one of the first surface and the second surface.
Hoss teaches wherein: the flexible substrate includes a first surface and a second surface opposite to the first surface (Claim 17: “a sensor substrate including a first side having a first surface area and defining a first side of the glucose sensor, and a second side having a second surface area and defining a second side of the glucose sensor”); at least one of a reference electrode, a working electrode, and a counter electrode is disposed on the first surface and the second surface ([0018]: “the sensors are double-sided, meaning that both sides of the sensor's substrate are electrochemically functional, i.e., each side provides at least one electrode”); and a plurality of connection terminals identical to the connection terminal are disposed on at least one of the first surface and the second surface (Claim 17: “a sensor substrate including a first side having a first surface area and defining a first side of the glucose sensor, and a second side having a second surface area and defining a second side of the glucose sensor, a first conductive layer disposed on the first side, wherein the first conductive layer substantially covers the first surface area, a second conductive layer disposed on the second side, wherein the second conductive layer substantially covers the second surface area”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiple surfaces from Hoss into the device from the Wang/Garai combination, since it allows the device to have more connections in different directions, which allows the device to accommodate more components and create more direct paths between the components of the device, as well as allow the device to process the signals it receives to provide further results to the user.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over the Wang/Garai combination as applied to claim 2 above, and further in view of Hoss and Wasson (US 20160262670).
Regarding claim 14, the Wang/Garai combination teaches the sensing device of claim 2.
However, the Wang/Garai combination does not teach wherein: the flexible substrate includes a first surface and a second surface opposite to the first surface and at least one of a reference electrode, a working electrode, and a counter electrode is disposed on the first surface and the second surface.
Hoss teaches wherein: the flexible substrate includes a first surface and a second surface opposite to the first surface (Hoss, Claim 17: “a sensor substrate including a first side having a first surface area and defining a first side of the glucose sensor, and a second side having a second surface area and defining a second side of the glucose sensor”), and at least one of a reference electrode, a working electrode, and a counter electrode is disposed on the first surface and the second surface (Hoss, [0018]: “the sensors are double-sided, meaning that both sides of the sensor's substrate are electrochemically functional, i.e., each side provides at least one electrode”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiple surfaces from Hoss into the device from the Wang/Garai combination, since it allows the device to have more connections in different directions, which allows the device to accommodate more components and create more direct paths between the components of the device, as well as allow the device to process the signals it receives to provide further results to the user.
However, the Wang/Garai/Hoss combination does not teach wherein the substrate is wound in a spiral shape such that the first surface faces outward and the second surface faces inward.
Wasson discloses a bandage type monitoring system. Specifically, Wasson teaches wherein the substrate is wound in a spiral shape such that the first surface faces outward and the second surface faces inward ([0046]: “A loop, dipole, or other type of antenna can be one or more layers of conductive material patterned on a surface (e.g., 150) of the flexible substrate 110 to form one or more specified conductive shapes (e.g., a ring, a spiral, a curved or straight line, an elliptical or rectangular patch, a fractal)”). Wang, Garai, Hoss, and Wasson are analogous arts as they are all related to sensor systems used for monitoring analyte levels.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to wind the substrate in a spiral shape as it allows the sensor to have more area and range to interact with the area it is sensing, providing more readings and a more accurate result.
Regarding claim 15, the Wang/Garai combination teaches the sensing device of claim 2.
However, the Wang/Garai combination does not teach wherein: the flexible substrate includes a first surface and a second surface opposite to the first surface and at least one of a reference electrode, a working electrode, and a counter electrode is disposed on the first surface and the second surface.
Hoss teaches wherein: the flexible substrate includes a first surface and a second surface opposite to the first surface (Hoss, Claim 17: “a sensor substrate including a first side having a first surface area and defining a first side of the glucose sensor, and a second side having a second surface area and defining a second side of the glucose sensor”), at least one reference electrode is disposed on the first surface; and at least one working electrode and at least one counter electrode are disposed on the second surface (Hoss, [0018]: “the sensors are double-sided, meaning that both sides of the sensor's substrate are electrochemically functional, i.e., each side provides at least one electrode”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiple surfaces from Hoss into the device from the Wang/Garai combination, since it allows the device to have more connections in different directions, as well as allow the device to process the signals it receives to provide further results to the user.
However, the Wang/Garai/Hoss combination does not teach wherein the substrate is wound in a spiral shape such that the first surface faces outward and the second surface faces inward.
Wasson teaches wherein the substrate is wound in a spiral shape such that the first surface faces outward and the second surface faces inward ([0046]: “A loop, dipole, or other type of antenna can be one or more layers of conductive material patterned on a surface (e.g., 150) of the flexible substrate 110 to form one or more specified conductive shapes (e.g., a ring, a spiral, a curved or straight line, an elliptical or rectangular patch, a fractal)”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to wind the substrate in a spiral shape as it allows the sensor to have more area and range to interact with the area it is sensing, providing more readings and a more accurate result.
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive. Applicant argues that Garai does not teach the support layer and the metal layer being received in a groove of a base, referencing Figures 14 and 15 of Garai. However, as stated above, Figures 14 and 15 of Garai are only illustrating a portion of the device, and Figs. 16 and 17 show the components of Figures 14 and 15 in a groove of a base, therefore this argument is not persuasive.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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